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Not yet recruiting NCT06859086

Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite

No phase Interventional Proximal Cavities of Posterior Teeth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: class II restoration.
Who it may be relevant to
Registry conditions: Proximal Cavities of Posterior Teeth. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite in Restoration of Proximal Lesions Over a Period Of 24 Months Follow-Up: A Randomized Clinical Trial

Overview

the aim of this study is To evaluate and compare the clinical performance of Self- Cure Bulk fill Composite Resin Versus Conventional Bulk fill resin composite in Restoration of Proximal Lesions over a Period of 24 months Follow-up.

Detailed description

Examination and selection of all patients will be done according to inclusion and exclusion criteria. A class II cavity will be prepared after local anesthesia has been given as required. Sectional matricing and wedging will be done.Followed by, placement of restorative material according to the randomization sequence.

For the intervention: The sectional matrix will be applied first, followed by filling of cavity with Self-Cure bulk-fill Resin Composite. (Stela Automix or Stela Capsule, SDI Ltd, Australia) For the control group: The sectional matrix will be applied first, followed by filling of the cavity with the bulk-fill resin composite material (Tetric N-Ceram Bulk Fill, Liechtenstein). Clinical evaluation will be done using USPHS criteria at 6,12,18 and 24 monthes follow up

Interventions

  • Procedure class II restoration
    A class II cavity will be prepared after local anesthesia has been given as requierd . Rubber dam isolation will be done. Sectional matricing and wedging will be done. Followed by placement of restorative material according to the randomization sequence.

Primary outcome measures

  • Marginal adaptation [Time frame: 24 months]
Secondary outcome measures (8)
  • Marginal discoloration [Time frame: 24 months]
  • Recurrent caries [Time frame: 24 months]
  • Retention analysis [Time frame: 24 months]
  • Surface roughness [Time frame: 24 months]
  • Postoperative sensitivity [Time frame: 24 months]
  • Anatomic form [Time frame: 24 months]
  • Proximal contact [Time frame: 24 months]
  • Color match [Time frame: 24 months]

Eligibility criteria

Patient-related criteria:

Inclusion criteria

  • Patients consulting in one of the outpatient clinics listed above.
  • Able to tolerate necessary restorative procedures.
  • Provide informed consent.
  • Accepts the 18 months follow-up period.

Exclusion criteria

  • Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
  • Pregnant women; as radiographs cannot be taken for them.
  • Allergy to any of the restorative materials, including anesthetics.
  • Uncooperative patients, will not abide by the instructions or attend the appointments.

Tooth related criteria:

Inclusion criteria

  • Teeth with primary proximal carious lesions.
  • Teeth are vital according to pulp-sensitivity tests.
  • Well-formed and fully-erupted in normal functional occlusion with natural antagonist and adjacent teeth.

Exclusion criteria

  • Deciduous teeth; as the study is targeting only permanent teeth.
  • Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
  • Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests), which would indicate irreversible pulpal damage.
  • Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion, which would indicate pulp necrosis.
  • Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.
  • Teeth with cervical caries; which can't be evaluated on periapical radiographs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT06859086 · SELF- CURE BULK-FILL RESIN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗